Nebulized Fentanyl in Patients With Mild to Moderate Interstitial Lung Disease and Chronic Dyspnea
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ClinicalTrials.gov Identifier: NCT03018756 |
Recruitment Status :
Completed
First Posted : January 12, 2017
Last Update Posted : April 25, 2022
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Condition or disease | Intervention/treatment | Phase |
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Interstitial Lung Disease | Drug: Fentanyl Citrate Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 21 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Use of Nebulized Fentanyl in Patients With Mild-to-Moderate Interstitial Lung Disease and Chronic Dyspnea |
Actual Study Start Date : | January 2017 |
Actual Primary Completion Date : | June 25, 2018 |
Actual Study Completion Date : | November 30, 2020 |

Arm | Intervention/treatment |
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Active Comparator: Fentanyl Citrate
Single dose, nebulized 100 mcg fentanyl citrate. This is a double-blind, placebo-controlled, two-period crossover study comparing the effects of a single dose of nebulized 100 mcg fentanyl citrate to that of a placebo (0.9% saline). Treatments will be in randomized order: patients in one study arm will receive fentanyl at the first treatment visit and placebo at the second treatment visit, patients in the other arm will receive placebo first and fentanyl second.
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Drug: Fentanyl Citrate
100 mcg fentanyl citrate will be inhaled via nebulizer.
Other Name: inhaled fentanyl |
Placebo Comparator: Placebo
Single dose, nebulized 0.9% saline solution. This is a double-blind, placebo-controlled, two-period crossover study comparing the effects of a single dose of nebulized 100 mcg fentanyl citrate to that of a placebo (0.9% saline). Treatments will be in randomized order: patients in one study arm will receive fentanyl at the first treatment visit and placebo at the second treatment visit, patients in the other arm will receive placebo first and fentanyl second.
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Drug: Placebo
0.9% saline solution will be inhaled via nebulizer
Other Name: normal saline |
- Dyspnea intensity measured by the 10-point Borg Scale at a standardized time during cycle ergometer exercise [ Time Frame: 10-minutes post-treatment ]The 10-point Borg scale ranges from 0 "nothing at all" to 10 "maximal/extremely strong" and will be used to rate the intensity of dyspnea during exercise: a decrease in this rating signifies an improvement. Dyspnea intensity will be assessed at a standardized time (4-minutes) in both post-treatment constant-load cycle ergometer tests.
- Diaphragm electromyography (EMGdi) at a standardized time during cycle exercise [ Time Frame: 10-minutes post-treatment ]EMGdi will be used as an index of inspiratory neural drive. Assessments will be compared at a standardized time (4-minutes) during both post-treatment constant-load cycle exercise tests.
- Ventilation at a standardized time during cycle exercise [ Time Frame: 10-minutes post-treatment ]Exercise measurements of minute ventilation will be compared at a standardized time (4-minutes) during both post-treatment constant-load cycle exercise tests.
- Breathing frequency at a standardized time during cycle exercise [ Time Frame: 10-minutes post-treatment ]Exercise measurements of breathing frequency (respiratory rate) will be compared at a standardized time (4-minutes) during both post-treatment constant-load cycle exercise tests.
- Tidal volume at a standardized time during cycle exercise [ Time Frame: 10-minutes post-treatment ]Exercise measurements of tidal volume will be compared at a standardized time (4-minutes) during both post-treatment constant-load cycle exercise tests.
- Inspiratory capacity at a standardized time during cycle exercise [ Time Frame: 10-minutes post-treatment ]Exercise measurements of inspiratory capacity will be compared at a standardized time (4-minutes) during both post-treatment constant-load cycle exercise tests.

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Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Fibrotic interstitial lung disease (ILD) diagnosis confirmed by specialty ILD clinic
- A total lung capacity (TLC) <lower limit of normal and ≥60%predicted, a forced vital capacity (FVC) <lower limit of normal and ≥60%predicted, and a forced expiratory volume in 1 second (FEV1)/FVC >70%.
- Clinically stable as defined by no changes in medication dosage or frequency of administration with no exacerbations or hospital admissions in the preceding 6 weeks.
- Moderate-to-severe chronic activity related dyspnea as defined by a Baseline Dyspnea Index total score ≤9, modified Medical Research Council score >1, or oxygen cost diagram.
- Ability to perform all study procedures and provide/sign informed consent.
Exclusion Criteria:
- Women of childbearing age who are pregnant or trying to become pregnant.
- Diffusing capacity of the lung for carbon monoxide (DLCO) <40 %predicted.
- Presence of active cardiopulmonary disease other than ILD that could contribute to dyspnea and exercise limitation.
- History of allergy or adverse reaction to fentanyl.
- History of allergy or adverse reaction to latex
- Presence of contraindications to pulmonary function or clinical exercise testing, including inability to exercise because of neuromuscular or musculoskeletal disease(s).
- Use of ambulatory oxygen or exercise-induced oxygen desaturation to < 80% on room air.
- Body mass index (BMI) <18.5 or ≥35.0 kg/m2.
- Use of antidepressant drugs (i.e., monoamine oxidase inhibitors, serotonin reuptake inhibitors) in the previous 2 weeks.
- Use of opioid drugs (e.g., morphine, fentanyl, oxycodone, codeine, etc.) in the previous 4 weeks.
Note: Healthy volunteers will only be used to assist in the characterization of the IPF study group, i.e., for comparison of baseline exercise responses. They will not undergo treatment.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03018756
Canada, Ontario | |
Respiratory Investigation Unit, Queen's University | |
Kingston, Ontario, Canada, K7L 2V7 |
Principal Investigator: | Denis E O'Donnell, MD, FRCPC | Queen's University |
Responsible Party: | Dr. Denis O'Donnell, Principal Investigator, Queen's University |
ClinicalTrials.gov Identifier: | NCT03018756 |
Other Study ID Numbers: |
DMED-1921-16 |
First Posted: | January 12, 2017 Key Record Dates |
Last Update Posted: | April 25, 2022 |
Last Verified: | April 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Lung Diseases Dyspnea Lung Diseases, Interstitial Respiratory Tract Diseases Respiration Disorders Signs and Symptoms, Respiratory Fentanyl Analgesics, Opioid Narcotics |
Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Adjuvants, Anesthesia Anesthetics, Intravenous Anesthetics, General Anesthetics |